The aim of the FingerKIt is to develop for the first time an end-to-end automated process chain for the production of custom-designed implants. With Fraunhofer IAPT in the lead, the consortium furthermore comprises the Fraunhofer Institutes IKTS, ITEM, IWM and MEVIS. The current focus is on the growing market for finger joint implants.
In Germany, over 5 million people are suffering from symptomatic osteoarthritis and some 1.5 million people from rheumatic diseases. Advanced cases could be treated by the developed technology. The comparatively small implants must meet high demands in terms of individual fit and biomechanical load. Compared to conventional endoprostheses for the replacement of knee and hip joints, the challenge in the area of finger joints is that the bones are much thinner and thus more fragile. Additionally, there is far less muscular tissue to support the finger-joint implants, increasing the risk of implant loosening compared to larger implants. The forms of therapy used so far, for rheumatoid arthritis or trauma for instance, very often result in a stiffening of the joints. Less than 20 percent of patients are pain-free and the complication rate amounts to 40 percent. The ultimate objective of the consortium is to enable a new form of treatment for this therapeutic area and thus achieve remobilization of finger joints by individually adjusted joint implants.
First of all, the Fraunhofer Institutes MEVIS and IWM are developing a model to create a 3D image from 2D X-rays of the damaged joint. By means of simulations, this individual implant will be adapted to meet the biomechanical requirements. Based on the adaptations, Fraunhofer IAPT will create an initial design of the implant, which will then be additively manufactured. The aim is to train an algorithm and thus automatically generate individual implant designs for additive manufacturing, or near-net-shape manufacturing, from the available simulation data. The Fraunhofer Institutes IAPT and IKTS are developing manufacturing technologies using selected materials so as to achieve increased biocompatibility and osseointegration and thus optimized adaptation of the implant to the original joint properties.
Together with the Fraunhofer Institutes IWM and IKTS, Fraunhofer ITEM is in charge of the ongoing validation of the implant properties. To this end, the institute is developing corresponding new in vivo models suitable for the materials and requirements. To ensure rapid transferability to clinical and industrial applications from the outset, all institutes involved are collectively working on cross-institutional, standards-compliant, digital documentation of their processes during the project.
In line with the Fraunhofer-Gesellschaft's 4D strategy, FingerKIt thus enables a paradigm shift with regard to the value chain of generating individual implants and unleashes completely new forms of patient care. Successful introduction of the FingerKIt process chain can for the first time provide the opportunity to take into account the regulatory requirements of the MDR already during process development.
Fraunhofer Institute for Toxicology and Experimental Medicine